Philips receives FDA Breakthrough Device Designation for laser-assisted IVC filter removal device

Rhea-AI Summary

On July 21, 2021, Royal Philips announced that the FDA granted Breakthrough Device Designation for its laser-assisted inferior vena cava (IVC) filter removal device. This device aims to address the high failure rate of current IVC filter removal methods, beneficial for over one million U.S. patients. Independent studies indicate that laser-assisted retrieval has a success rate of 96-99% with minimal adverse events. The FDA's designation ensures Philips receives priority review, enhancing access to innovative medical technology aimed at improving patient care.

Positive

• FDA Breakthrough Device Designation granted for the laser-assisted IVC filter removal device.
• High success rate of 96-99% for laser-assisted retrieval indicated by clinical studies.
• Potential to significantly reduce long-term complications for over one million patients with IVC filters.

Negative

• High failure rate for existing IVC filter removal methods highlighted, indicating a pressing need for better solutions.

July 21, 2021

• FDA Breakthrough Device Designation is granted to novel medical devices that have the potential to provide more effective treatment
• It is estimated that in the United States more than one million patients with inferior vena cava (IVC) filters would benefit from filter removal to reduce the risk of long-term complications
• Laser for IVC filter removal is intended to safely ablate tissue to remove embedded filters
• Limited options exist for embedded IVC filter removal, and independent studies indicate high success rates using a Philips excimer laser sheath 

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the FDA has granted Breakthrough Device Designation (BDD) for a laser-assisted inferior vena cava (IVC) filter removal device. The proposed device is intended for ablating tissue to remove an IVC filter when previous methods of removal have failed.

IVC filters are used to treat patients with venous thromboembolism, in which blood clots form in the deep veins of the leg, groin or arm and can travel through the circulatory system. They are placed in the inferior vena cava to capture blood clots from moving to the heart or lungs. Research has shown that IVC filters may have long-term complications [1]. The filters can fracture and travel through the bloodstream to other parts of the body. Other identified long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. The FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated [2].

The failure rate for IVC filter removal is high and limited options for removal exist if the filter has become difficult to remove. Advanced retrieval tools and techniques are required if the IVC filter becomes embedded in the vasculature [3]. Physicians have very few tools to remove the filter when this happens and there are no FDA-approved devices for this type of advanced removal.

Recent research supports laser-assisted removal

Two independent and prospective clinical studies demonstrated that laser-assisted retrieval was 96-99% effective with a major adverse event rate of 0.7-2% [3][4].

“Laser-assisted filter retrieval may be a critical tool for the safe retrieval of filters with extended implantation times,” said Kush R Desai, MD, FSIR, Associate Professor of Radiology, Surgery, and Medicine, and Director of Deep Venous Interventions at Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. “Breakthrough Device Designation reflects the potential impact that this technology could have on countless patients where this technology can be applied to safely retrieve filters by an expert physician, thereby reducing their risk of significant filter-related complications.”

“There is a clear need for an innovative device to help physicians more safely perform advanced IVC filter removal and I believe that the Philips excimer laser sheath may greatly enhance the options available to succeed in filter retrieval,” said Atul Gupta, MD, Interventional Radiologist and Chief Medical Officer, Image Guided Therapy, at Philips. “Breakthrough Device Designation is an important step for a medical innovation such as this one to help fill an unmet need in patient care.”

FDA Breakthrough Device Designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to breakthrough medical devices. Under the program, the FDA will provide Philips with priority review and interactive communication regarding device development throughout the submission process.

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[1] Van Ha, T. G. Complications of inferior vena caval filters. Semin. Interv. Radiol. 23, 150–155 (2006).
[2] Health, C. for D. and R. Safety Communications - Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. (2014). Available at: http://wayback.archive-it.org/7993/20170722215731/ https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm.
[3] Kuo, W. et al. Laser‐Assisted Removal of Embedded Vena Cava Filters: A First‐In‐Human Escalation Trial in 500 Patients Refractory to High‐Force Retrieval. Journal of the American Heart Association 9:24, 1-9 (2020). https://www.ahajournals.org/doi/pdf/10.1161/JAHA.119.017916
[4] Desai, K. et al. Excimer Laser Sheath-Assisted Retrieval of “Closed-Cell” Design Inferior Vena Cava Filters. J Am Heart Assoc; 9: e017240 (2020).

For further information, please contact:

Joost Maltha
Philips Global Press Office
Tel: +31 610 558 116
Email: joost.maltha@philips.com
Twitter: JoostMaltha

Fabienne van der Feer
Philips Image Guided Therapy
Tel: +31 622 698 001
Email: fabienne.van.der.feer@philips.com
Twitter: FC_Feer

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 17.3 billion and employs approximately 77,000 employees with sales and services in more than 100 countries. News about Philips can be found at http://www.philips.com/newscenter

Attachment

• Philips Headquarters Amsterdam

FAQ

What is the significance of the FDA Breakthrough Device Designation for PHG?

The FDA Breakthrough Device Designation for PHG's laser-assisted IVC filter removal device allows for priority review and enhances communication about the device's development.

How effective is the laser-assisted IVC filter removal device developed by PHG?

Clinical studies show the laser-assisted IVC filter retrieval method has a success rate of 96-99%, making it a promising solution for difficult removals.

How many patients in the U.S. could benefit from the IVC filter removal device by PHG?

It is estimated that over one million patients in the U.S. could benefit from the IVC filter removal procedure, reducing the risk of long-term complications.

What are the long-term risks associated with IVC filters mentioned in the PHG press release?

The long-term risks include filter fracture, lower limb deep vein thrombosis, and IVC occlusion, reinforcing the need for effective removal methods.